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Bydureon (Exenatide) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Bydureon (Exenatide) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (218)
Death (10)
Life Threatening Events (20)
Disability (1)

Reports by Reaction Type

Blood Glucose Increased (38)Nausea (24)Weight Decreased (23)Injection Site Nodule (23)Off Label Use (22)Dizziness (19)Urticaria (17)Injection Site Erythema (16)Diarrhoea (14)Injection Site Haemorrhage (13)Dyspnoea (12)Injection Site Pain (12)

Below are a few examples of reports where side effects / adverse reactions may be related to Bydureon (Exenatide). For a complete list or a specific selection of reports, please use the links above.

Possible Bydureon side effects in female

Reported by a physician from Denmark on 2012-08-27

Patient: female, weighing 88.0 kg (193.6 pounds)

Reactions: Hydrocholecystis, Cholecystitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Bydureon

Other drugs received by patient: Metformin HCL; Simvastatin



Possible Bydureon side effects in female

Reported by a physician from United States on 2012-08-23

Patient: female

Reactions: Hyperglycaemia, Blood Glucose Increased

Drug(s) suspected as cause:
Bydureon

Other drugs received by patient: Lantus



Possible Bydureon side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-22

Patient: female

Reactions: Facial Bones Fracture, Injection Site Pain, Loss of Consciousness

Drug(s) suspected as cause:
Bydureon

Other drugs received by patient: Victoza



Possible Bydureon side effects in 59 year old male

Reported by a physician from Germany on 2012-08-22

Patient: 59 year old male

Reactions: Hypoxic-Ischaemic Encephalopathy, Depressed Level of Consciousness, Myocardial Infarction

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Bydureon



Possible Bydureon side effects in male

Reported by a consumer/non-health professional from Sweden on 2012-08-21

Patient: male

Reactions: Dysphagia, Pharyngeal Oedema, Vomiting, Diarrhoea

Drug(s) suspected as cause:
Bydureon

Other drugs received by patient: Felodipine; Lantus; Antihypertensives



Possible Bydureon side effects in 36 year old female

Reported by a consumer/non-health professional from Germany on 2012-08-21

Patient: 36 year old female, weighing 89.0 kg (195.8 pounds)

Reactions: Maternal Exposure During Pregnancy, Abortion Spontaneous

Drug(s) suspected as cause:
Bydureon

Other drugs received by patient: Metformin



Possible Bydureon side effects in

Reported by a consumer/non-health professional from Germany on 2012-08-20

Patient:

Reactions: Dysphagia, Swelling Face, Abdominal Distension, Rash, Respiratory Distress, Abdominal Pain Upper

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Bydureon

Other drugs received by patient: Levothyroxine Sodium; Diabesin; Irbesartan



Possible Bydureon side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-20

Patient: male, weighing 90.7 kg (199.5 pounds)

Reactions: Abdominal Pain Lower, Blood Glucose Decreased, Cardiac Discomfort, Heart Rate Irregular, Stress, Atrioventricular Block First Degree

Drug(s) suspected as cause:
Bydureon
    Dosage: 2 mg, weekly (1/w)
    Indication: Type 2 Diabetes Mellitus

Byetta
    Dosage: 10 ug, bid
    Indication: Type 2 Diabetes Mellitus
    Start date: 2011-10-01
    End date: 2012-01-01

Other drugs received by patient: Lisinopril; Amaryl; Lisinopril



Possible Bydureon side effects in 56 year old male

Reported by a consumer/non-health professional from Germany on 2012-08-20

Patient: 56 year old male

Reactions: Urinary Tract Infection Enterococcal, Nephrolithiasis, Prostate Cancer, Calculus Ureteric

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Bydureon
    Dosage: 2 mg, weekly (1/w)
    Indication: Type 2 Diabetes Mellitus
    Start date: 2011-11-17

Byetta
    Dosage: unk, unknown
    Indication: Type 2 Diabetes Mellitus
    Start date: 2009-04-01
    End date: 2011-11-17

Other drugs received by patient: Atacand; Aspirin; Simvastatin; Metoprolol Tartrate; Metformin HCL



Possible Bydureon side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-20

Patient: male

Reactions: Cholelithiasis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Bydureon
    Dosage: 2 mg, weekly (1/w)
    Start date: 2012-04-01
    End date: 2012-07-01

Bydureon
    Dosage: 2 mg, weekly (1/w)
    Start date: 2012-07-01



Possible Bydureon side effects in female

Reported by a physician from United States on 2012-08-17

Patient: female

Reactions: Diarrhoea, Nausea, Aspartate Aminotransferase Increased, Alanine Aminotransferase Increased

Drug(s) suspected as cause:
Bydureon



Possible Bydureon side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-17

Patient: male, weighing 90.2 kg (198.5 pounds)

Reactions: Weight Decreased, Haemorrhoids, Anaemia, Constipation, Faeces Discoloured, Haematochezia, Asthenia, Proctalgia

Drug(s) suspected as cause:
Bydureon

Other drugs received by patient: Actoplus MET



Possible Bydureon side effects in male

Reported by a consumer/non-health professional from Germany on 2012-08-17

Patient: male

Reactions: Carotid Artery Stenosis, Coronary Angioplasty, Cholecystectomy

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Bydureon
    Dosage: 2 mg, weekly (1/w)
    Indication: Type 2 Diabetes Mellitus
    Start date: 2012-05-01

Byetta
    Dosage: 5 ug, unknown
    Indication: Type 2 Diabetes Mellitus
    Start date: 2009-08-01
    End date: 2009-12-01

Byetta
    Dosage: 10 ug, unknown
    Start date: 2009-12-01
    End date: 2012-05-01

Other drugs received by patient: Metformin Hydrochloride; Furosemid-Ratiopharm / 00032601 /; Pravastatin; Allopurinol; Novaminosulfon; Clopidogrel Bisulfate and Aspirin; Eprosartan Mesylate; Tamsulosin HCL; Neuro-Lichtenstein; Candesartan Cilexetil; Magnesium Verla / 00648601 /; Nebivolol



Possible Bydureon side effects in male

Reported by a consumer/non-health professional from Germany on 2012-08-14

Patient: male

Reactions: Glycosylated Haemoglobin Increased, Injection Site Inflammation, Injection Site Haemorrhage, Injection Site Abscess, Injection Site Pain, Injection Site Nodule

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Bydureon

Other drugs received by patient: Loratadine; Atacand; Metformin HCL



Possible Bydureon side effects in female

Reported by a consumer/non-health professional from Germany on 2012-08-13

Patient: female

Reactions: Abdominal Discomfort, General Physical Condition Abnormal, Nausea, Dizziness

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Bydureon

Other drugs received by patient: Metformin Hydrochloride



Possible Bydureon side effects in female

Reported by a physician from United States on 2012-08-13

Patient: female

Reactions: Injection Site Erythema, Injection Site Urticaria, Injection Site Nodule, Injection Site Pruritus

Drug(s) suspected as cause:
Bydureon



Possible Bydureon side effects in female

Reported by a physician from United States on 2012-08-09

Patient: female, weighing 100.7 kg (221.5 pounds)

Reactions: Pancreatic Neoplasm

Drug(s) suspected as cause:
Bydureon

Other drugs received by patient: Atorvastatin; Levoxyl; Vitamin D; Metformin Hydrochloride; Glimepiride



Possible Bydureon side effects in 51 year old female

Reported by a physician from United States on 2012-08-08

Patient: 51 year old female, weighing 128.4 kg (282.4 pounds)

Reactions: Respiratory Arrest, Cardiac Arrest, Acute Myocardial Infarction

Adverse event resulted in: death

Drug(s) suspected as cause:
Bydureon



Possible Bydureon side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-03

Patient: female, weighing 105.2 kg (231.5 pounds)

Reactions: Pruritus Generalised, Swelling Face, Hypersensitivity, Arthralgia, Local Swelling, Headache

Drug(s) suspected as cause:
Bydureon
    Dosage: 2 mg, weekly (1/w)
    Indication: Type 2 Diabetes Mellitus
    Start date: 2012-04-28
    End date: 2012-06-15

Byetta
    Dosage: unk
    Indication: Type 2 Diabetes Mellitus
    Start date: 2010-01-01
    End date: 2012-04-27

Other drugs received by patient: Vitamin E; Metformin Hydrochloride; Multi-Vitamin



Possible Bydureon side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-03

Patient: female, weighing 79.4 kg (174.6 pounds)

Reactions: Pharyngeal Oedema, Vomiting, Malaise, Nausea, Chills, Asthenia, Injection Site Nodule

Drug(s) suspected as cause:
Bydureon

Other drugs received by patient: Januvia; Januvia; Glimepiride



Possible Bydureon side effects in female

Reported by a physician from United Kingdom on 2012-08-03

Patient: female

Reactions: Abdominal Pain, Weight Decreased, Vomiting, Pain in Extremity, Oedema Peripheral

Drug(s) suspected as cause:
Bydureon



Possible Bydureon side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-03

Patient: female, weighing 94.3 kg (207.5 pounds)

Reactions: Parkinson's Disease, Tremor, Activities of Daily Living Impaired, Chest Pain, Dissociation, Presyncope, Cold Sweat, Feeling Abnormal

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Bydureon

Other drugs received by patient: Gabapentin; Mirapex; Glipizide; Carbidopa and Levodopa; Metformin Hydrochloride



Possible Bydureon side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-03

Patient: female, weighing 114.3 kg (251.4 pounds)

Reactions: Abdominal Pain, Confusional State, Contusion, Pain, Injection Site Pain, Wound Secretion, Injection Site Erythema, Fatigue, Staphylococcal Infection, Skin Lesion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Bydureon



Possible Bydureon side effects in male

Reported by a physician from United States on 2012-08-03

Patient: male, weighing 92.5 kg (203.6 pounds)

Reactions: Nausea, Lipase Increased, Decreased Appetite, Decreased Interest

Drug(s) suspected as cause:
Bydureon



Possible Bydureon side effects in male

Reported by a consumer/non-health professional from United Kingdom on 2012-08-03

Patient: male

Reactions: LIP Swelling, Flushing, Pruritus, Malaise, Feeling Hot, Rash Pruritic

Drug(s) suspected as cause:
Bydureon
    Dosage: 2 mg, weekly (1/w)
    Indication: Type 2 Diabetes Mellitus
    Start date: 2012-03-22
    End date: 2012-04-01

Byetta

Other drugs received by patient: Warfarin Sodium; Furosemide; Isosorbide Mononitrate; Ezetimibe; Fenofibrate; Pregabalin; Spironolactone; ACE Inhibitors; Cholecalciferol; Lansoprazole; Rosuvastatin; Carvedilol



Possible Bydureon side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-03

Patient: female, weighing 65.8 kg (144.7 pounds)

Reactions: Abdominal Pain, Diarrhoea, Diarrhoea Haemorrhagic

Drug(s) suspected as cause:
Bydureon

Other drugs received by patient: Carvedilol; Effient; Pantoprazole; Atorvastatin; Aspirin / USA /; Wellbutrin



Possible Bydureon side effects in 77 year old female

Reported by a consumer/non-health professional from Germany on 2012-07-31

Patient: 77 year old female

Reactions: Atrial Fibrillation, Feeling Abnormal

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Bydureon



Possible Bydureon side effects in female

Reported by a pharmacist from United States on 2012-07-31

Patient: female

Reactions: Staphylococcal Infection, Product Contamination

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Bydureon



Possible Bydureon side effects in male

Reported by a physician from Germany on 2012-07-30

Patient: male

Reactions: Vasculitis

Drug(s) suspected as cause:
Bydureon



Possible Bydureon side effects in male

Reported by a consumer/non-health professional from Netherlands on 2012-07-30

Patient: male

Reactions: Weight Decreased, Urticaria, Faeces Hard

Drug(s) suspected as cause:
Bydureon

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